About the job
The Quality Manager is responsible for providing Quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance. The Quality Manager works closely with Operations personnel and Environmental Monitoring Technicians to complete on-the-floor audits and training of behavior and technique.
Responsibilities include, but are not limited to:
• Report on QA events related to maintenance of appropriate conditions within clean rooms with a focus on GMP guidelines as amended by Directive 2003/94/EC, and 91/412/EEC respectively
• Provides review of production specific Deviations / Investigations, Change Controls
• Assist in generating procedures related to Manufacturing QA functions / activities
• Periodically review records to verify that quality standards for each product is met
• Maintain compliance with cGMP guidelines and state laws
• Prepares weekly/monthly reports, prepares metrics (Key Performance Indicators) and trends data to identify and prioritize continuous improvement opportunities
• Responsible to maintain all testing equipment in compliance, calibration and certification
• Promptly communicates with Operations regarding complaints, product issues/variances
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed
• Conduct and report the findings of internal investigations of compliance issues
Set yourself apart
You possess the following qualifications, background and abilities:
•Pharmacy/ Chemistry/Biology degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
• Minimum 2 years directly related experience supporting compliance in a quality/compliance function/applicable compliance field.
• Ability to effectively communicate
• Decision making ability
• Oversight of operations
• Ability to multi-task and prioritize
• Experience supporting compliance in a quality/compliance/ function /applicable compliance field preferred
• Knowledge of QMS and CAPA related tools or systems is preferred.
• Environmental, monitoring or audit experience is an asset
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.